MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FULL RADIUS BONECUTTER, 5.5MM, PLATINUM; SAW, POWERED, AND ACCESSORIES

Model Number 72202530

Device Problem Device Slipped (1584)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/27/2017

Event Type  malfunction  

Event Description

It was reported that during an arthroscopic knee procedure (in the knee joint): flakes have come loose from the full radius bonecutter.The loose flakes are removed from the knee.No procedure delay or patient injuries were reported.

Manufacturer Narrative

One 72202530 full radius 5.5mm bonecutter platinum blade reported on.The complaint stated ¿it was reported that during an arthroscopic knee procedure (in the knee joint): flakes have come loose from the full radius bone cutter.The loose flakes are removed from the knee.No procedure delay or patient injuries were reported¿.The device was not returned yet, although the customer has forwarded a photo.Initial evaluation indicates skiving wear bands on the inside of the outer blade.Shedding has been found to be consistent with wear bands created from inadvertent excess side loading pressure being applied to the device.

Manufacturer Narrative

The device was initially evaluated based upon information reported and customer photo.Initial evaluation still applies.Indications of surface skiving on the inside of the outer blade were physically confirmed.It was also confirmed that there are several locations of rotational material skiving on the outer surface of the inner blade.Shedding has been found to be consistent with inadvertent excess side loading pressure being applied to the device.Excessive ¿side-loading¿ on the blade during use does not improve cutting performance and in extreme cases may result in wear and degradation of the inner assembly.Irreversible damage to blades or burrs will result if they are run without the flow of irrigation (dry).Platinum; of the silver family, has been listed as bio-compatible.Platinum has been used to improve performance of the device and does not have an adverse effect on patient safety.No further actions pursued at this time.If relevant information becomes available to assist with evaluation, the complaint will certainly be revisited.

• Brand Name: FULL RADIUS BONECUTTER, 5.5MM, PLATINUM
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: jim gonzales ; 7000 west william cannon drive; austin, TX 78735
• MDR Report Key: 7152179
• MDR Text Key: 96052806
• Report Number: 1219602-2017-01605
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010655684
• UDI-Public: (01)03596010655684(17)200308(10)50684163
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/08/2020
• Device Model Number: 72202530
• Device Catalogue Number: 72202530
• Device Lot Number: 50684163
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/27/2017
• Initial Date FDA Received: 12/28/2017
• Supplement Dates Manufacturer Received: 02/19/2018; 02/19/2018
• Supplement Dates FDA Received: 02/19/2018; 03/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1